The U.S. SEC reported a settlement Feb. 23 with Baxter International Inc. and its former treasurer, Scott Bohaboy, and former assistant treasurer, Jeffrey Schaible, resolving charges involving years of improper intra-company foreign exchange transactions that resulted in the misstatement of Baxter’s net income.

Tariffs applied to goods imported for China were imposed by the Trump administration as part of a larger effort to reset the U.S. trade deficit, but there were several exclusions for medical devices in the interest of maintaining access.

The U.S. FDA has at last published what is nominally a draft rule for harmonization of the Quality System Regulation (QSR) with an international standard, ISO 13485, but the draft rule is conspicuous for the absence of specifics.

Abbott Laboratories’ Cardiomems heart failure (HF) system is open to a larger patient population following an expanded approval from the FDA. Abbott’s system had previously been approved for class III HF patients that had been hospitalized for HF in the past year. A new expanded indication enables the sensor to be utilized by class II (earlier stage) HF patients and those whose blood test show elevated levels of biomarkers known as natriuretic peptides. The FDA based the approval on findings from the GUIDE-HF trial, which suggested class II HF patients and patients with elevated natriuretic peptides had better outcomes when their therapy was guided by pulmonary pressure monitoring, with a 34% and 25% reduction in heart failure hospitalizations and emergency visits, respectively, based on study data adjusted for the impact of COVID-19.

The FDA’s device center has long been at the task of reclassifying legacy devices that promise a moderate degree of risk, but successful de novo device applications also call for a class II listing. The agency recently posted five such risk classifications, including for a device developed by Edwards Lifesciences Corp., of Irvine, Calif.

Engineers at Atlanta-based Georgia Tech’s Center for 3D Medical Fabrication have developed a 3D-printed tracheal splint as an airway for children born with a rare condition known as tracheal agenesis or the absence of a trachea or windpipe.

The Biden administration has posted a request for information (RFI) about the conditions necessary for the in vitro diagnostic industry to sustain testing capacity for communicable disease outbreaks, although the letter commits to no specific actions. The Advanced Medical Technology Association responded to the RFI with the recommendation that the administration quickly commit to the provision of resources as a means of ensuring that “market volatility will no longer determine test availability.”

The FDA’s device center has been eyeing an overhaul of its Quality System Regulation (QSR) for several years, and the latest development is the scheduling of a March 2 advisory committee hearing to review the proposal. The default assumption is that the agency will post the draft rule prior to the hearing, although the routine two-day window for reviewing FDA meeting materials prior to an advisory hearing might leave stakeholders with insufficient time to examine the agency’s proposal.

As the Biden administration continues to play musical chairs with key U.S. federal health leadership positions, its latest move is naming Francis Collins to serve as science adviser to the president and co-chair of the President’s Council of Advisers on Science and Technology.